OptiNose Files Investigational New Drug Application to use Sumatriptan Delivered with its Novel Drug Delivery Technology
YARDLEY, Pa., Feb 02, 2012 (BUSINESS WIRE) -- OptiNose Inc. announces the filing of an Investigational New Drug (IND) with the U.S. Food and Drug Administration (FDA) in December, 2011. The FDA has completed its review and has notified OptiNose that the studies under this IND may proceed. The Company will initiate Phase III trials in adults with acute migraine with or without aura utilizing its novel intranasal technology.
"This filing signals an important milestone in our quest to deliver improved relief to patients who suffer from migraine headaches, "said Peter Miller, Chief Executive Officer (CEO) of OptiNose. "Based on our clinical study results to date, we are encouraged by the potential of the OptiNose technology and the significant impact it could have on patients with this debilitating condition."
About OptiNose Inc.
OptiNose is a drug delivery company with breakthrough bi-directional nasal technology set to transform the static nasal drug delivery market. Founded in 2000, OptiNose's devices are designed to deliver intranasal drugs to target regions of the nasal cavity, including the sinuses and the olfactory region while preventing lung deposition. The company offers both single and multi-use intranasal delivery devices for liquid and powder formulations. The technology has been tested in a number of clinical trials assessing both clinical efficacy and safety.
About Bi-directional Nasal Delivery Technology
OptiNose's bidirectional nasal delivery technology significantly improves delivery to the targeted sites deep into the nose. While exhaling into the device, the soft palate automatically closes off the nasal cavity completely. The breath enters one nostril through a sealing nozzle and triggers the release of drug particles into the airflow. This action causes the narrow nasal passages to expand and carry these particles beyond the nasal valve to targeted sites. After delivering drug particles to the targeted sites, the air flow then exits the nasal cavity through the other nasal passage in the opposite direction.
SOURCE: OptiNose Inc.
Dan Zacchei, 212-446-1882